Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

Recruitment Status: ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2025 by Ocular Therapeutix, Inc.
Sponsor: Ocular Therapeutix, Inc.
Information Provided by (Responsible Party): Ocular Therapeutix, Inc.

Clinicaltrials.gov Identifier: NCT06223958
Other Study ID Numbers:: OTX-TKI-2023-AMD-301

First Submitted: January 11, 2024
First Posted: January 24, 2024
Last Update Posted: April 17, 2025
Last Verified: March 2025

ClinicalTrials.gov processed this data on April 2025. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Neovascular Age-Related Macular Degeneration	Drug: OTX-TKI (axitinib implant)Drug: Aflibercept

Study Design

Study Type	Interventional
Actual Enrollment	344 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
Official Title	A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Study Start Date	January 28, 2024
Actual Primary Completion Date	1w 4d from now
Actual Study Completion Date	1yr 5mos from now

Groups and Cohorts

Group/Cohort	Intervention/Treatment
OTX-TKI (axitinib implant)	Drug: OTX-TKI (axitinib implant) Intravitreal Injection of OTX-TKI (axitinib implant)
Control	Drug: Aflibercept Injection of 2mg (0.05mL) of aflibercept

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity (BCVA)
Maintenance of visual acuity, defined as \< 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening. Are at least older than 50 years of age at Day 1. Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA
Exclusion Criteria	Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening. Have evidence of a scar, fibrosis, or atrophy of \> 50% of the total lesion in the study eye.

Contacts and Locations

Sponsors and Collaborators	Ocular Therapeutix, Inc.
Locations	Associated Retina Consultants - Gilbert \| Gilbert Arizona, United States, 85297Associated Retina Consultants - Phoenix \| Phoenix Arizona, United States, 85020Retinal Research Institute \| Phoenix Arizona, United States, 85053Retina Macula Institute of Arizona \| Scottsdale Arizona, United States, 85255CA CRC California Retina Consultants \| Bakersfield California, United States, 93103The Retina Partners - Encino \| Encino California, United States, 91436Retina Consultants of Orange County - Fullerton \| Fullerton California, United States, 92835Atlantis Eyecare \| Huntington Beach California, United States, 92647Lakeside Vision Center - Irvine \| Irvine California, United States, 92604Retina-Vitreous Associates Medical Group - Los Angeles \| Los Angeles California, United States, 90017-4886CA RCMG Retinal Consultants Medical Group, Inc. \| Modesto California, United States, 95356Retina Sacramento MSO, LLC \| Modesto California, United States, 95356Kaiser Permanente Division of Research \| Oakland California, United States, 94611CA CRC California Retina Consultants \| Oxnard California, United States, 93103Stanford University School of Medicine, Byers Eye Institute \| Palo Alto California, United States, 94303Doheny Eye Center \| Pasadena California, United States, 91105AzulVision \| Pasadena California, United States, 91107Orange County Retina Medical Group \| Santa Ana California, United States, 92705California Retina Consultants (CRC) - Santa Barbara \| Santa Barbara California, United States, 93103-4211Macula Retina Vitreous Center \| Torrance California, United States, 90505Bay Area Retina Associates, A Medical Group \| Walnut Creek California, United States, 94598Retina Consultants of Southern Colorado - Colorado Springs \| Colorado Springs Colorado, United States, 80909RSC Research, PLLC \| Denver Colorado, United States, 80210Colorado Retina Associates (CRA) - Lakewood \| Lakewood Colorado, United States, 80228Retina Group of New England, PC \| Waterford Connecticut, United States, 06385The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC) \| Clearwater Florida, United States, 33761Rand Eye Institute \| Deerfield Beach Florida, United States, 33064Speciality Retina Center \| Deerfield Beach Florida, United States, 33064Retina Group of Florida - Fort Lauderdale \| Fort Lauderdale Florida, United States, 33308-1909Florida Retina Institute - Lake Mary \| Lake Mary Florida, United States, 32746-2175Florida Retina Consultants - Lakeland \| Lakeland Florida, United States, 33805South Florida Retina Institute \| Miami Florida, United States, 33145Retina Specialty Institute - Pensacola \| Pensacola Florida, United States, 32503-2030MedEye Associates - Miami \| South Miami Florida, United States, 33143Retina Vitreous Associates of Florida (RVA) - Saint Petersburg \| St. Petersburg Florida, United States, 33711-1141Retina Vitreous Associates of Florida - Tampa \| Tampa Florida, United States, 33607Retina Associates of Florida LLC Tampa MacDill \| Tampa Florida, United States, 33609Southeast Retina Center, P.C. - Augusta \| Augusta Georgia, United States, 30909-6440Illinois Eye and Ear Infirmary at UI Health UIC \| Chicago Illinois, United States, 60612Illinois Retina Associates, S.C. - Lincoln Park \| Chicago Illinois, United States, 60657-7227University Retina and Macula Associates, P.C. \| Oak Forest Illinois, United States, 60452Springfield Clinic \| Springfield Illinois, United States, 62703IN AVRUC Associated Vitreoretinal and Uveitis Consultants \| Carmel Indiana, United States, 46290Retina Partners Midwest \| Indianapolis Indiana, United States, 46290-1166Wolfe Eye Clinic \| West Des Moines Iowa, United States, 50266-7705Maine Eye Center - Marginal Way Campus \| Portland Maine, United States, 04101-2438The Wilmer Eye Institute \| Baltimore Maryland, United States, 21287Mid Atlantic Retina Specialists - Hagerstown \| Hagerstown Maryland, United States, 21740-5846Cumberland Valley Retina Consultants \| Hagerstown Maryland, United States, 21740Henry Ford Hospital \| Detroit Michigan, United States, 48202Associated Retinal Consultants P.C. (ARC) - Royal Oak \| Royal Oak Michigan, United States, 48073Retina Consultants of Minnesota \| Edina Minnesota, United States, 55435Mississippi Baptist Medical Center \| Jackson Mississippi, United States, 39202-2064Pepose Vision Institute \| Chesterfield Missouri, United States, 63017Retina Research Institute, LLC \| St Louis Missouri, United States, 63144-1317Sierra Eye Associates \| Reno Nevada, United States, 89502-1605The Retina Center Of New Jersey, LLC - Bloomfield \| Bloomfield New Jersey, United States, 07003Long Island Vitreoretinal Consultants (VRC) - Hauppauge \| Hauppauge New York, United States, 11788Retina-Vitreous Surgeons of Central New York \| Liverpool New York, United States, 13088NY LIVRC Long Island Vitreoretinal Consultants \| Shirley New York, United States, 11967Asheville Eye Associates (AEA) - Retinal Office \| Asheville North Carolina, United States, 28803Duke University Health System - Duke Eye Center Of North Durham \| Durham North Carolina, United States, 27705Retina Associates of Cleveland, Inc. - Beachwood \| Beachwood Ohio, United States, 44122Retina Associates of Cleveland \| Cleveland Ohio, United States, 44130Retina Associates of Cleveland, Inc. - Youngstown \| Youngstown Ohio, United States, 44505Erie Retina Research \| Erie Pennsylvania, United States, 16507Palmetto Retina Center \| Aiken South Carolina, United States, 29802Charleston Neuroscience Institute LLC - Beaufort \| Beaufort South Carolina, United States, 29902SC CNI Retina Consultants of Charleston \| Beaufort South Carolina, United States, 29902Charleston Neuroscience Institute LLC - Charleston \| Charleston South Carolina, United States, 29414Palmetto Retina Center \| Florence South Carolina, United States, 29501Charleston Neuroscience Institute \| Ladson South Carolina, United States, 29456Retina Consultants of Charleston - Mount Pleasant \| Mt. Pleasant South Carolina, United States, 29464Palmetto Retina Center \| West Columbia South Carolina, United States, 29169-2429Black Hills Regional Eye Institute (BHREI) \| Rapid City South Dakota, United States, 57701-7374Vance Thompson Vision \| Sioux Falls South Dakota, United States, 57108Charles Retina Institute PC \| Germantown Tennessee, United States, 38138-2405Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location \| Nashville Tennessee, United States, 37203-1596West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA) \| Abilene Texas, United States, 79606Texas Retina Associates (TRA) - Arlington \| Arlington Texas, United States, 76012-2505Retina Consultants of Austin PA (RCA) - Central Austin \| Austin Texas, United States, 78705-1023Austin Retina Associates, PLLC \| Austin Texas, United States, 78705-1169Keystone Research \| Austin Texas, United States, 78731Retina Research Center (RRC) \| Austin Texas, United States, 78750-2302Retina Consultants of Texas Beaumont \| Beaumont Texas, United States, 77707Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas) \| Bellaire Texas, United States, 77401Star Vision Consultants \| Burleson Texas, United States, 76028Texas Retina Center \| Houston Texas, United States, 77030Retina Consultants of Texas - Katy \| Katy Texas, United States, 77494Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location \| San Antonio Texas, United States, 78240-1502Retinal Consultants of Texas - San Antonio Medical Center \| San Antonio Texas, United States, 78240TX RCTX Retina Consultants of Texas \| San Antonio Texas, United States, 78240Retina Consultants of Houston \| The Woodlands Texas, United States, 77384Retina Associates of Utah, P.C - Intermountain Medical Center Location \| Salt Lake City Utah, United States, 84107-6767Wagner Macula & Retina Center - Norfolk, VA Office \| Norfolk Virginia, United States, 23502-3933Vistar Eye Center Vision and Surgery Specialists \| Roanoke Virginia, United States, 24019Eye Clinic of Wisconsin \| Wausau Wisconsin, United States, 54403Buenos Aires Macula \| Pilar Buenos Aires, Argentina, B1629AHJCentro Oftalmologico Dr. Charles S.A \| Buenos Aires Buenos Aires F.D., Argentina, 1121Organizacion Medica de Investigacion OMI \| Buenos Aires Buenos Aires F.D., Argentina, C1015Fundacion Zambrano - Cirugia Ocular \| Buenos Aires Buenos Aires F.D., Argentina, C1023AAQInstituto Oftalmologico de Alta Complejidad \| Buenos Aires Buenos Aires F.D., Argentina, C1120AANOftalmologia Global \| Rosario Santa Fe Province, Argentina, S2000Centro Privado de Ojos Romagosa SA \| Córdoba , Argentina, X5000AAIOftar Mendoza Srl Centro Privado de Oftalmologia \| Mendoza , Argentina, M5500GGKCentrovision \| Mendoza , Argentina, M5500Laser Vision Group \| Santa Fe , Argentina, S2126DTOEmanuelli research and development \| Arecibo , Puerto Rico, 612

Sponsors and Collaborators

Ocular Therapeutix, Inc.

Locations

Associated Retina Consultants - Gilbert | Gilbert Arizona, United States, 85297Associated Retina Consultants - Phoenix | Phoenix Arizona, United States, 85020Retinal Research Institute | Phoenix Arizona, United States, 85053Retina Macula Institute of Arizona | Scottsdale Arizona, United States, 85255CA CRC California Retina Consultants | Bakersfield California, United States, 93103The Retina Partners - Encino | Encino California, United States, 91436Retina Consultants of Orange County - Fullerton | Fullerton California, United States, 92835Atlantis Eyecare | Huntington Beach California, United States, 92647Lakeside Vision Center - Irvine | Irvine California, United States, 92604Retina-Vitreous Associates Medical Group - Los Angeles | Los Angeles California, United States, 90017-4886CA RCMG Retinal Consultants Medical Group, Inc. | Modesto California, United States, 95356Retina Sacramento MSO, LLC | Modesto California, United States, 95356Kaiser Permanente Division of Research | Oakland California, United States, 94611CA CRC California Retina Consultants | Oxnard California, United States, 93103Stanford University School of Medicine, Byers Eye Institute | Palo Alto California, United States, 94303Doheny Eye Center | Pasadena California, United States, 91105AzulVision | Pasadena California, United States, 91107Orange County Retina Medical Group | Santa Ana California, United States, 92705California Retina Consultants (CRC) - Santa Barbara | Santa Barbara California, United States, 93103-4211Macula Retina Vitreous Center | Torrance California, United States, 90505Bay Area Retina Associates, A Medical Group | Walnut Creek California, United States, 94598Retina Consultants of Southern Colorado - Colorado Springs | Colorado Springs Colorado, United States, 80909RSC Research, PLLC | Denver Colorado, United States, 80210Colorado Retina Associates (CRA) - Lakewood | Lakewood Colorado, United States, 80228Retina Group of New England, PC | Waterford Connecticut, United States, 06385The Macula Center - Clearwater Office (Suncoast Retina Consultants, LLC) | Clearwater Florida, United States, 33761Rand Eye Institute | Deerfield Beach Florida, United States, 33064Speciality Retina Center | Deerfield Beach Florida, United States, 33064Retina Group of Florida - Fort Lauderdale | Fort Lauderdale Florida, United States, 33308-1909Florida Retina Institute - Lake Mary | Lake Mary Florida, United States, 32746-2175Florida Retina Consultants - Lakeland | Lakeland Florida, United States, 33805South Florida Retina Institute | Miami Florida, United States, 33145Retina Specialty Institute - Pensacola | Pensacola Florida, United States, 32503-2030MedEye Associates - Miami | South Miami Florida, United States, 33143Retina Vitreous Associates of Florida (RVA) - Saint Petersburg | St. Petersburg Florida, United States, 33711-1141Retina Vitreous Associates of Florida - Tampa | Tampa Florida, United States, 33607Retina Associates of Florida LLC Tampa MacDill | Tampa Florida, United States, 33609Southeast Retina Center, P.C. - Augusta | Augusta Georgia, United States, 30909-6440Illinois Eye and Ear Infirmary at UI Health UIC | Chicago Illinois, United States, 60612Illinois Retina Associates, S.C. - Lincoln Park | Chicago Illinois, United States, 60657-7227University Retina and Macula Associates, P.C. | Oak Forest Illinois, United States, 60452Springfield Clinic | Springfield Illinois, United States, 62703IN AVRUC Associated Vitreoretinal and Uveitis Consultants | Carmel Indiana, United States, 46290Retina Partners Midwest | Indianapolis Indiana, United States, 46290-1166Wolfe Eye Clinic | West Des Moines Iowa, United States, 50266-7705Maine Eye Center - Marginal Way Campus | Portland Maine, United States, 04101-2438The Wilmer Eye Institute | Baltimore Maryland, United States, 21287Mid Atlantic Retina Specialists - Hagerstown | Hagerstown Maryland, United States, 21740-5846Cumberland Valley Retina Consultants | Hagerstown Maryland, United States, 21740Henry Ford Hospital | Detroit Michigan, United States, 48202Associated Retinal Consultants P.C. (ARC) - Royal Oak | Royal Oak Michigan, United States, 48073Retina Consultants of Minnesota | Edina Minnesota, United States, 55435Mississippi Baptist Medical Center | Jackson Mississippi, United States, 39202-2064Pepose Vision Institute | Chesterfield Missouri, United States, 63017Retina Research Institute, LLC | St Louis Missouri, United States, 63144-1317Sierra Eye Associates | Reno Nevada, United States, 89502-1605The Retina Center Of New Jersey, LLC - Bloomfield | Bloomfield New Jersey, United States, 07003Long Island Vitreoretinal Consultants (VRC) - Hauppauge | Hauppauge New York, United States, 11788Retina-Vitreous Surgeons of Central New York | Liverpool New York, United States, 13088NY LIVRC Long Island Vitreoretinal Consultants | Shirley New York, United States, 11967Asheville Eye Associates (AEA) - Retinal Office | Asheville North Carolina, United States, 28803Duke University Health System - Duke Eye Center Of North Durham | Durham North Carolina, United States, 27705Retina Associates of Cleveland, Inc. - Beachwood | Beachwood Ohio, United States, 44122Retina Associates of Cleveland | Cleveland Ohio, United States, 44130Retina Associates of Cleveland, Inc. - Youngstown | Youngstown Ohio, United States, 44505Erie Retina Research | Erie Pennsylvania, United States, 16507Palmetto Retina Center | Aiken South Carolina, United States, 29802Charleston Neuroscience Institute LLC - Beaufort | Beaufort South Carolina, United States, 29902SC CNI Retina Consultants of Charleston | Beaufort South Carolina, United States, 29902Charleston Neuroscience Institute LLC - Charleston | Charleston South Carolina, United States, 29414Palmetto Retina Center | Florence South Carolina, United States, 29501Charleston Neuroscience Institute | Ladson South Carolina, United States, 29456Retina Consultants of Charleston - Mount Pleasant | Mt. Pleasant South Carolina, United States, 29464Palmetto Retina Center | West Columbia South Carolina, United States, 29169-2429Black Hills Regional Eye Institute (BHREI) | Rapid City South Dakota, United States, 57701-7374Vance Thompson Vision | Sioux Falls South Dakota, United States, 57108Charles Retina Institute PC | Germantown Tennessee, United States, 38138-2405Tennessee Retina, PC - Nashville - Centennial Professional Plaza Location | Nashville Tennessee, United States, 37203-1596West Texas Retina Consultants (WTRC) - Abilene (Ophthalmology Specialists of Texas, PA) | Abilene Texas, United States, 79606Texas Retina Associates (TRA) - Arlington | Arlington Texas, United States, 76012-2505Retina Consultants of Austin PA (RCA) - Central Austin | Austin Texas, United States, 78705-1023Austin Retina Associates, PLLC | Austin Texas, United States, 78705-1169Keystone Research | Austin Texas, United States, 78731Retina Research Center (RRC) | Austin Texas, United States, 78750-2302Retina Consultants of Texas Beaumont | Beaumont Texas, United States, 77707Retina Group, Inc. d/b/a Retina Consultants of America (Retina Consultants of Texas) | Bellaire Texas, United States, 77401Star Vision Consultants | Burleson Texas, United States, 76028Texas Retina Center | Houston Texas, United States, 77030Retina Consultants of Texas - Katy | Katy Texas, United States, 77494Medical Center Ophthalmology Associates (MCOA) - Northwest Clinic Location | San Antonio Texas, United States, 78240-1502Retinal Consultants of Texas - San Antonio Medical Center | San Antonio Texas, United States, 78240TX RCTX Retina Consultants of Texas | San Antonio Texas, United States, 78240Retina Consultants of Houston | The Woodlands Texas, United States, 77384Retina Associates of Utah, P.C - Intermountain Medical Center Location | Salt Lake City Utah, United States, 84107-6767Wagner Macula & Retina Center - Norfolk, VA Office | Norfolk Virginia, United States, 23502-3933Vistar Eye Center Vision and Surgery Specialists | Roanoke Virginia, United States, 24019Eye Clinic of Wisconsin | Wausau Wisconsin, United States, 54403Buenos Aires Macula | Pilar Buenos Aires, Argentina, B1629AHJCentro Oftalmologico Dr. Charles S.A | Buenos Aires Buenos Aires F.D., Argentina, 1121Organizacion Medica de Investigacion OMI | Buenos Aires Buenos Aires F.D., Argentina, C1015Fundacion Zambrano - Cirugia Ocular | Buenos Aires Buenos Aires F.D., Argentina, C1023AAQInstituto Oftalmologico de Alta Complejidad | Buenos Aires Buenos Aires F.D., Argentina, C1120AANOftalmologia Global | Rosario Santa Fe Province, Argentina, S2000Centro Privado de Ojos Romagosa SA | Córdoba , Argentina, X5000AAIOftar Mendoza Srl Centro Privado de Oftalmologia | Mendoza , Argentina, M5500GGKCentrovision | Mendoza , Argentina, M5500Laser Vision Group | Santa Fe , Argentina, S2126DTOEmanuelli research and development | Arecibo , Puerto Rico, 612